ISO 13485:2016 Lead Auditor Training for Medical Devices Quality Management Systems

ISO 13485 Lead Auditor Training for Medical Devices

Course Duration: 5 Days - 8 Hours/day

Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global-MD, Exemplar Global-AU and Exemplar Global-TL Competency Units. This 5-Day ISO 13485 training course fully covers the ISO 13485:2016 requirements. Other topics include audit systems, the auditing process and audit instruments; the documentation process, conducting an audit, writing the audit report and evaluating corrective actions. Auditing case studies will be used to develop the required auditing skills based on ISO 19011.

This class also covers the comparable 21 CFR 820 content(FDA QMSR) for additional guidance for organizations in the Medical Device sector.

Attendees who successfully pass the exams during this course will achieve a Certificate of Attainment for the following competency units:

• Exemplar Global-MD
• Exemplar Global-AU
• Exemplar Global-TL